BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3217076 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01309
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    October 5, 2011
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (MULTI-ORGAN FAILURE, RUPTURE OR DISSECTION, RETROGRADE AORTIC DISSECTION, STROKE, TRANSIENT ISCHEMIC ATTACK, OPEN REPAIR CONVERSION, TYPE I ENDOLEAK); (UNKNOWN CAUSE OF EVENTS); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE DISSECTED THORACIC AORTA AND PRE-OPERATIVE RUPTURED ANEURYSM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE DISSECTED THORACIC AORTA AND PRE-OPERATIVE RUPTURED ANEURYSM); (UNKNOWN CAUSE OF EVENTS).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MIDTERM RESULTS AFTER ENDOVASCULAR TREATMENT OF ACUTE, COMPLICATED TYPE B AORTIC DISSECTION: THE TALENT THORACIC REGISTRY. MAREK P. EHRLICH, MD,HERVE ROUSSEAU, MD, ROBIN HEIJMEN, MD, PHILIPPE PIQUET, MD, JEAN-PAUL BEREGI, MD, CHRISTOPH A. NIENABER, MD, GOTTFRIED SODECK, MD, AND ROSSELLA FATTORI, MD. (J THORAC CARDIOVASC SURG 2013;145:159-65) OBJECTIVE: TO ASSESS THE EFFICACY AND MIDTERM RESULTS OF ENDOVASCULAR TREATMENT OF ACUTE COMPLICATED TYPE B DISSECTION. METHODS: FROM JANUARY 1998 TO MARCH 2004, 29 PATIENTS (7 WOMEN AND 22 MEN) WITH ACUTE COMPLICATED AORTIC TYPE B DISSECTION (MEAN AGE, 61 YEARS; RANGE, 22¿78), DEFINED AS AORTIC RUPTURE, MALPERFUSION, INTRACTABLE PAIN, OR UNCONTROLLED HYPERTENSION, UNDERWENT ENDOVASCULAR STENT GRAFT PLACEMENT WITH THE MEDTRONIC TALENT DEVICE. FIVE PATIENTS (17%) HAD UNDERGONE PREVIOUS SURGERY ON THE ASCENDING AORTA AND/OR AORTIC VALVE. THE MEAN AORTIC DIAMETER AT INTERVENTION WAS 48 +/-13 MM. FOLLOW-UP WAS 100% COMPLETE AND AVERAGED 53 +/- 41 MONTHS. RESULTS: THE TECHNICAL FEASIBILITY AND SUCCESS WITH DEPLOYMENT PROXIMAL TO THE ENTRY TEAR WAS 100%, REQUIRING PARTIAL OR TOTAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY IN ONLY 1 PATIENT (3%). HOSPITAL MORTALITY WAS 17% +/- 7% (70%CONFIDENCE LIMIT) WITH 6 LATE DEATHS. THE CAUSES OF HOSPITAL DEATH INCLUDED MULTIORGAN FAILURE IN 2 PATIENTS, AORTIC RUPTURE IN 2, AND RETROGRADE DISSECTION IN 1 PATIENT. THREE PATIENTS (10%) WHO SURVIVED THE PROCEDURE DEVELOPED NEUROLOGIC COMPLICATIONS (2 STROKES AND 1 TRANSIENT ISCHEMIC ATTACK). ONE PATIENT REQUIRED EARLY CONVERSION TO SURGERY BECAUSE OF RETROGRADE TYPE A DISSECTION. FURTHERMORE, 4 PATIENTS DEVELOPED A TYPE IA ENDOLEAK. A POST PROCEDURAL INCREASE IN THE DISTAL AORTIC DIAMETER WAS OBSERVED IN 3 PATIENTS. THE ACTUARIAL SURVIVAL AT 1 AND 5 YEARS WAS 79% AND 61%, RESPECTIVELY. FREEDOM FROM TREATMENT FAILURE AT 1 AND 5 YEARS (INCLUDING RE-INTERVENTION, AORTIC RUPTURE, DEVICE-RELATED COMPLICATIONS, AORTIC-RELATED DEATH, OR SUDDEN, UNEXPLAINED LATE DEATH) WAS 82% AND 77%, RESPECTIVELY. CONCLUSIONS: ENDOVASCULAR STENT GRAFT PLACEMENT IN ACUTE COMPLICATED TYPE B AORTIC DISSECTION PROVES TO BE A PROMISING ALTERNATIVE T HERAPEUTIC TREATMENT MODALITY IN THIS RELATIVELY DIFFICULT PATIENT COHORT. REFINEMENTS, ESPECIALLY IN STENT DESIGN AND APPLICATION, COULD FURTHER IMPROVE THE PROGNOSIS OF PATIENTS IN THIS LIFE THREATENING SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317794 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death